At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed transitional cell carcinoma with prior cystectomy or nephroureterectomy
- ✓Surgery within 16 weeks of first vaccination
- ✓At least 4 weeks post-surgery before first vaccination
- ✓Radiological imaging confirms no evidence of disease within 1 month of first vaccination
- ✕Clinically significant heart disease (NYHA Class III or IV)
- ✕Severe PPD reaction with >40 mm induration
- ✕Prior malignancy within 5 years treated with extensive chemotherapy/radiation or with evidence of metastasis
- ✕Serious infections requiring antibiotics, bleeding disorders, or antibiotic use within 5 days of treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NY-ESO-1 Protein Immunization of Post-Cystectomy or Post-Nephroureterectomy Patients With Transitional Cell Carcinomas
In Brief
A Phase 1 clinical trial evaluating TICE®-strain BCG, NY-ESO-1 protein, and 1 other intervention for Transitional Cell Carcinoma. Completed, enrolled 6 participants across 1 site.
Detailed Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas.